Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
Check against the official notice below — it lists the full affected range.
Novartis is recalling blister packages of Sandimmune® and Neoral® prescription medications containing 100 mg soft gelatin capsules because the packaging does not meet child-resistant packaging requirements under the Poison Prevention Packaging Act. The recalled products pose a risk of poisoning if young children open and swallow the contents. The recall affects specific lot numbers and expiration dates of both medications; consumers should check their package labeling against the lot numbers and NDC numbers listed in the recall to determine if their medication is affected.
Consumers with recalled medication should immediately secure the product out of sight and reach of children. According to the recall notice, consumers should contact Novartis to request a free child-resistant pouch for storing the blister packages and may continue taking the medication as directed while using the protective pouch until new child-resistant blister packaging becomes available.
Written by software from the official notice below. Not reviewed by a lawyer.
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PPPA), posing a risk of poisoning if the contents are swallowed by young children.
Consumers should immediately secure the product out of the sight and reach of children and contact the firm to request a free child-resistant pouch in which to store the blister package medications. Consumers can continue to use the medication as directed. The child-resistant pouches should be used to store these medications until new child-resistant blister packaging is available.
This recall involves blister packages of prescription medications Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules from Novartis. Packages of Sandimmune 100 mg contain three blister cards with ten soft gelatin capsules per card and packages of Neoral 100 mg contain five blister cards with six soft gelatin capsules per card. The recalled blister packages have "Novartis," the name of the medication, dosage, NDC, lot number and expiration date on the outer package and on the blister cards. Only 100 mg doses of these medications with the following NDC and lot numbers and expiration dates are included in this recall: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules 0078-0241-15 0078-0241-61 APCA136 APCA339 APCA793 APCC238 09/2020 02/2021 01/2022 07/2022 Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules 0078-0248-15 0078-0248-61 APCA437 APCA979 07/2020 03/2021
Official record: U.S. Consumer Product Safety Commission ↗
Republished from the official source above; details can change — the source record controls.